The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more
Activist NLRB Created More Problems For All Employers in 2016 - What Happens Under President Trump? During 2016, the National Labor Relations Board (NLRB or the Board) maintained its generally pro-union, anti-employer...more
On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more
As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more
Last week, President Obama signed the 21st Century Cures Act (the “Cures Act”), which contains numerous provisions touching on a wide range of public health matters. Among the provisions is the creation of a new health...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more
On December 13, 2016, President Obama signed the 21st Century Cures Act (the Act) that provides government funding and support for a number of health care initiatives. Significantly, the last section of the Act eases...more
The Qualified Small Employer Health Reimbursement Arrangement (QSEHRA), part of the 21st Century Cures Act signed into law by President Barack Obama on December 13, 2016, makes available to small employers a new option to...more
On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more
On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
House Leadership Elections: Republican House leadership changes remain in flux in the wake of Speaker John Boehner's (R-OH) decision to retire and the unexpected delay of the vote to select his successor. House Majority...more
On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more
On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more
On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more
This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more
This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more
On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures...more
The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health...more
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more